Metrogel

Metrogel

MetroGel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Metrogel (metronidazole) topical (for the skin) is used to treat skin lesions caused by rosacea. It is an antibiotic. This medication is available in generic form. Common side effects include stinging, burning, skin irritation, dryness, redness, metallic taste, nausea, or headache.

Dose: Apply and rub in a thin film of Metrogel once daily to affected area(s). Metrogel may interact with a blood thinner such as warfarin (Coumadin). It is not likely that other drugs you take orally or inject will have an effect on topically applied Metrogel. Many drugs can interact with each other. Tell your doctor all prescription and over-the-counter medications and supplements you use. Metrogel should be used only when prescribed during pregnancy. This drug passes into breast milk. Consult your doctor before breast-feeding.

Our Metrogel (metronidazole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

MetroGel in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have severe stinging or burning when you apply metronidazole topical.

Less serious side effects may include:

  • mild burning or stinging when the medication is applied;
  • numbness or tingly feeling in your hands or feet;
  • cough, stuffy nose, sore throat, cold symptoms;
  • vaginal itching or discharge;
  • headache;
  • dry, scaly, or itchy skin;
  • nausea; or
  • metallic taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for MetroGel (Metronidazole) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

MetroGel Overview - Patient Information: Side Effects

SIDE EFFECTS: Stinging, burning, skin irritation, dryness, redness, metallic taste, nausea, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have this unlikely but serious side effect: tingling or numbness of the hands and feet.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for MetroGel (Metronidazole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

MetroGel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a controlled clinical trial, 557 patients used metronidazole gel, 1% and 189 patients used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥ 1%:

Table 1: Adverse Reactions That Occurred at a Rate of ≥ 1%

System Organ Class/Preferred Term Metronidazole Gel, 1%
N= 557
Gel Vehicle
N= 189
Patients with at least one AE
Number (%) of Patients
186 (33.4) 51 (27.0)
Infections and infestations 76 (13.6) 28 (14.8)
  Bronchitis 6 (1.1) 3 (1.6)
  Influenza 8 (1.4) 1 (0.5)
  Nasopharyngitis 17 (3.1) 8 (4.2)
  Sinusitis 8 (1.4) 3 (1.6)
  Upper respiratory tract infection 14 (2.5) 4 (2.1)
  Urinary tract infection 6 (1.1) 1 (0.5)
  Vaginal mycosis 1 (0.2) 2 (1.1)
Musculoskeletal and connective tissue disorders 19 (3.4) 5 (2.6)
  Back pain 3 (0.5) 2 (1.1)
Neoplasms 4 (0.7) 2 (1.1)
  Basal cell carcinoma 1 (0.2) 2 (1.1)
Nervous system disorders 18 (3.2) 3 (1.6)
  Headache 12 (2.2) 1 (0.5)
Respiratory, thoracic and mediastinal disorders 22 (3.9) 5 (2.6)
  Nasal congestion 6 (1.1) 3 (1.6)
Skin and subcutaneous tissue disorders 36 (6.5) 12 (6.3)
  Contact dermatitis 7 (1.3) 1 (0.5)
  Dry skin 6 (1.1) 3 (1.6)
Vascular disorders 8 (1.4) 1 (0.5)
  Hypertension 6 (1.1) 1 (0.5)

Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline

Sign/Symptom Metronidazole Gel, 1%
N= 544
Gel Vehicle
N= 184
Dryness 138 (25.4) 63 (34.2)
  Mild 93 (17.1) 41 (22.3)
  Moderate 42 (7.7) 20 (10.9)
  Severe 3 (0.6) 2 (1.1)
Scaling 134 (24.6) 60 (32.6)
  Mild 88 (16.2) 32 (17.4)
  Moderate 43 (7.9) 27 (14.7)
  Severe 3 (0.6) 1 (0.5)
Pruritus 86 (15.8) 35 (19.0)
  Mild 53 (9.7) 21 (11.4)
  Moderate 27 (5.0) 13 (7.1)
  Severe 6 (1.1) 1 (0.5)
Stinging/burning 56 (10.3) 28 (15.2)
  Mild 39 (7.2) 18 (9.8)
  Moderate 7 (1.3) 9 (4.9)
  Severe 10 (1.8) 1 (0.5)

The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.

Post Marketing Experience

The following adverse reaction has been identified during post approval use of topical metronidazole: peripheral neuropathy. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for MetroGel (Metronidazole) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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